CLINICAL TRIAL: NON-ALCOHOLIC STEATOHEPATITIS CLINICAL RESEARCH NETWORK

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 通过多学科和多中心合作小组的合作努力，阐明非酒精性脂肪性肝病（NAFLD）的病因、自然史、诊断、治疗和预防，特别是其更严重的NASH及其并发症。构建一个由网络招募的具有广泛严重程度的NAFLD患者的大型队列数据库。核心数据收集将包括临床、人口统计学、实验室、影像学和组织学特征。建立一个组织库，包括从招募的患者中获得的血清、肝组织、DNA和尿液。在非糖尿病和糖尿病患者亚组中进行NAFLD治疗新方法的2期和3期试验。为制定NAFLD诊断和分期标准的临床和病理标准提供资源，为制定NAFLD治疗研究的临床和病理标准以及最佳措施和终点提供资源，为NAFLD发病机制、自然史和治疗的辅助研究提供资源，并启动NAFLD有希望治疗的3期试验。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment and prevention of nonalcoholic fatty liver disease (NAFLD) and in particular its more severe form of NASH and its complications. Construct a database of a large cohort of patients with NAFLD with a broad range of severity, recruited by the network. Core data collection will include clinical, demographic, laboratory, imaging and histological features. Develop a tissue bank comprising serum, liver tissue, DNA and urine obtained from recruited patients. Undertake Phase 2 and 3 trials of new approaches to the therapy of NAFLD in non-diabetic and diabetic patient subgroups. Provide a resource for developing clinical and pathological criteria for standardizing diagnotsic and staging criteria for NAFLD, provide a resource for developing clinical and pathological criteria and best measures and endpoints for therapeutic studies of NAFLD, provide a resource for ancillary studies of the pathogenesis, natural history and treatment of NAFLD, and initiate phase 3 trials of promising therapies for NAFLD.